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Impact of custom-made orthopedic footwear and plantar orthoses on quality of life and functionality of patients with diabetic neuropathic foot: a randomized clinical trial
Botelho M, Pais S, Guerreiro C, Fernandez E, Gonzalez M
Diabetes Epidemiology and Management 2022 Jan-Mar;5:100040
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIMS: Determine the effectiveness of custom-made orthopedic footwear (OF) and total contact plantar orthoses (PO) on the quality of life (QoL) and functionality of people with type 2 diabetes with diabetic peripheral neuropathic (DPN). METHODS: Randomized clinical study with 2 parallel intervention groups and pre- and post-test analysis. In the standard footwear group (SFg), PO and education on foot self-care were applied and in the orthopedic footwear group (OFg) the same intervention was applied, but with personalized OF. A total of 43 type 2 diabetic patients with DPN aged 61 to 76 years were randomized: 20 in to SFg and 23 to OFg. Michigan Neuropathy Screening Instrument (MNSI) was used to screen for DPN. QoL was assessed with Short Form-36 and functional level was evaluated by Lower Extremity Functional Scale (LEFS), 6 physical tests and center of pressure (CoP) oscillation. RESULTS: No differences in QoL were found between groups. OFg showed a better functional reach and mediolateral displacement of CoP (p <= 0.05). CONCLUSIONS: The OF does not show evidence on functional and QoL improvement in low-risk type 2 diabetic patients with neuropathy but both groups improved significantly in functional tests. The PO showed clinical value in these patients, so a regular and specialized treatment with appropriate footwear and plantar orthoses can play an important role in reducing the complications of diabetic neuropathy.

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